Cleared Traditional

NPG III CASTING ALLOY

K915247 · Aalba Dent, Inc. · Dental
Dec 1991
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K915247 is an FDA 510(k) clearance for the NPG III CASTING ALLOY, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on December 30, 1991, 45 days after receiving the submission on November 15, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K915247 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1991
Decision Date December 30, 1991
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710